AORTIC ANEURYSM CLAMP - AORTIC ANEURYSM CLAMP ATRAUMATIC JAW - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: AORTIC ANEURYSM CLAMP ATRAUMATIC JAW

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More Product Details

Catalog Number

441-744

Brand Name

AORTIC ANEURYSM CLAMP

Version/Model Number

441-744

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092544

Product Code Details

Product Code

DXC

Product Code Name

Clamp, Vascular

Device Record Status

Public Device Record Key

6e1f855d-cc07-4f57-ad64-91a52a9305ff

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414